Bruker MALDI Biotyper Brochure

MALDI Biotyper CA System

Clinical Application for Identification of Microorganisms

Innovation with Integrity MALDI-TOF

In Microbiology,
Every Minute Counts

The MALDI Biotyper CA System

A powerful technology for abundant proteins that are found in all
better results microorganisms.
The characteristic patterns of these
To help answer key challenges in Clinical highly abundant proteins are used to
Microbiology, Bruker has utilized its many reliably and accurately identify a par-
years of experience to create the truly ticular microorganism by matching the
groundbreaking MALDI Biotyper CA respective pattern with an extensive
System. With its combination of perfor- FDA-cleared database to determine the
mance and utility, the MALDI Biotyper identity of the microorganism.
CA System will revolutionize the way
microbial identification is performed in Enterobacter aerogenes Mass Spectrum Profile
the clinical microbiology laboratory.

Accuracy comparable to Nucleic Acid
Sequencing
Much faster than traditional methods
Cost effective
Robust and easy to use
A true benchtop system

Identifying microorganisms by
their molecular fingerprint

The MALDI Biotyper CA System identi-
fies microorganisms using MALDI-TOF
(Matrix Assisted Laser Desorption Ioniza-
tion Time of Flight) Mass Spectrometry
to measure a unique molecular fingerprint
of an organism. Specifically, the MALDI
Biotyper CA System measures highly

A Simple Procedure for a
Sophisticated Platform

Innovative design leads to automates the process of acquiring the
enhanced performance and mass spectrum and performing the data-
productivity base matching. A report is then gener-
ated showing the microbial identification
The MALDI Biotyper CA System in a very easy to interpret “traffic light”
workflow has been designed to be as color scheme.
robust and easy to perform as possible.
No previous experience with Mass Typically no more than an isolated single
Spectrometry is required. The workflow colony from a culture plate is required,
has been streamlined and requires only a the entire procedure requires only a few
few simple steps to generate high quality minutes to complete providing a report
microorganism identifications. Our dedi- showing the closest matches to the
cated microbiology software extensive library of microorganisms.

Select an Smear using Add matrix up
isolated colony any sterile transfer to one hour after

Export result device transfer
to AST/LIS
MALDI Biotyper Add to MALDI-TOF
CA System project list
Sample
Workflow

Final review by Software automatically
microbiologist generates MALDI-TOF

Spectrum instantly spectrum
matched against

reference database to
give identification

Easy to Use Software that is
Dedicated to Microbiology

The wizard
A simple to use Real Time Classification wizard guides you through setting up
samples for analysis in just a few easy steps.

Automatic Calibration and Quality Control Check

The MALDI Biotyper CA System microflex LT/SH mass spectrometer is
automatically checked using US IVD BTS (Bacterial Test Standard) before
each use. When the check is successful, the system automatically
begins the measurement process.

Run Results Report

After the acquisition of the
spectral data has been
completed, a Run Results
Report can be generated.
The resultant report for
each sample shows the
best match along with the
respective matching score.
Organism identification
hints can also be viewed
via a hyperlink.

Rigorous and Sophisticated Data
Analysis Assures Accuracy

Meaning of score values Score Values
Reference Strain
The spectrum of the unknown test
organism, acquired through the MALDI
Biotyper CA System Software, is elec-
tronically transformed into the peak list.
Using a biostatistical algorithm, this peak
list is compared to reference peak lists of
organisms in the reference database and
a log(score) value between 0.00 and 3.00
is calculated.

The higher the log(score) value, the
higher the degree of similarity to a given
organism in the reference FDA-cleared
database. A log(score) value of ≥ 2.00
can be considered an excellent probabi-
lity for test organism identification at the
species level.

The main spectra concept:
a reference database developed
with the user in mind

Reference database entries in the
MALDI Biotyper CA System are stored
as Main Spectra (MSP). These MSPs are
based on multiple measurements of a
single defined strain to ensure that the
true biological variability of an organism
has been captured.

An unbiased sophisticated algorithm
creates the MSP completely unsuper-
vised by extracting information about
peak position, intensity and frequency,
while employing very effective de-
noising and patented mass corrections to
the peak data.

Unknowns are then compared to the
MSP FDA-cleared database using a
superior pattern-matching approach that
is based on true statistical multi-variant
analysis; and includes peak positions,
intensities and frequencies ensuring the
highest possible levels of accuracy and
reproducibility across the complete range
of microbes.

The Best Technology from the
Market Leader in MALDI-TOF

The MALDI Biotyper CA System was Silent and pleasant operation—
developed by Bruker, the industry With WhisperMode™ you really have
leader in MALDI-TOF technology. These a system that can sit on a bench next
systems were designed as robust, com- to you almost silently. By eliminating
pact, high performance platforms noisy oil-based vacuum pumps, the
intended for extensive and routine usage. vacuum system is not only quiet, but
Many outstanding features have been virtually maintenance free.
incorporated into the MALDI Biotyper
CA System to enhance performance, Greatly enhanced sensitivity—
simplify operation, and extend system With the most sensitive detector
lifetime and utility. technology available (FlashDetector™)
you will benefit from having the same
A true bench-top system—A smart high performance technology as large
compact design that packs a punch research grade instruments.
with a throughput of 192 samples an
hour. The small access chamber allows
for a rapid target insertion that elimina-
tes waiting time between runs.
Requires only a 110 V electrical outlet
with very minimal heat output.

Powerful and Reliable Performance—
Benchtop Convenience

microflex LT/SH Mass Spectrometer Dimensions and Operating Parameters

LxWxH: 510 x 680 x 1093 mm [20.1” x 26.8” x 43”]
Weight: 84 kg (185 lb) net weight
Noise: < 30 dB under normal operating conditions
Temp Range: 10-30ºC (50-86ºF)
Operating Humidity: 15-85% non-condensing @ 30ºC

Full spectrum resolution

Patented, intelligent pulsed Ion Extraction resolution and separation, and mitigates
across a wide protein mass range. the need for unnecessarily long and bulky
This unique technology enhances peak instrument flight tubes.

MALDI Biotyper CA System and
Components

Components US IVD 48 Spot Target [P/N: 604532]
US IVD BTS [P/N: 604530]
The standard MALDI Biotyper CA System US IVD HCCA portioned [P/N: 604531]
contains the following components: Package Insert, MALDI Biotyper CA
System User Manual
microflex LT/SH mass spectrometer [P/N: 603291]
[P/N: 269944] Uninterruptible Power Supply (UPS)
MALDI Biotyper CA System desktop [P/N: 601463]
computer running under Windows® 7
[P/N: 604941]
MALDI Biotyper CA System software
[P/N: 604512]

Instrument: microflex LT/SH Mass Spectrometer

Nitrogen Laser with 60Hz repetition rate WhisperModeTM
Full Spectrum Resolution (FSR) with Oil-free membrane pre-vacuum pump
broadband focusing mode (PANTM) and turbo pump
FlashDetectorTM

Indication for use

The Bruker Daltonics, Inc. MALDI Bio- The MALDI Biotyper CA System is indi-
typer CA System is a qualitative in vitro cated for use in conjunction with other
diagnostic mass spectrometer system clinical and laboratory findings to aid in
for the identification of Gram-negative the diagnosis of Gram-negative bacterial
bacterial colonies cultured from human infections.
specimens using matrix-assisted laser
desorption/ionization time of flight
(MALDI-TOF) mass spectrometry
technology.

The following organisms are claimed:

Achromobacter xylosoxidans Hafnia alvei
Acinetobacter lwoffii Klebsiella pneumoniae
Acinetobacter radioresistens Klebsiella_oxytoca / Raoultella_ornithinolytica
Acinetobacter ursingii Moraxella_sg_Branhamella catarrhalis
Moraxella_sg_Moraxella osloensis
Acinetobacter baumannii complex Morganella morganii
Acinetobacter baumannii Pantoea agglomerans
Acinetobacter calcoaceticus Pasteurella multocida
Acinetobacter nosocomialis Proteus mirabilis
Acinetobacter pittii
Proteus vulgaris group
Aeromonas sp Proteus hauseri
Aeromonas allosaccharophila Proteus penneri
Aeromonas caviae Proteus vulgaris
Aeromonas culicicola Providencia rettgeri
Aeromonas hydrophila Providencia stuartii
Aeromonas ichthiosmia Pseudomonas aeruginosa
Aeromonas veronii
Aeromonas sobria Pseudomonas fluorescens group
Alcaligenes faecalis Pseudomonas azotoformans
Burkholderia gladioli Pseudomonas brenneri
Burkholderia multivorans Pseudomonas cedrina
Pseudomonas congelans
Burkholderia cepacia complex Pseudomonas corrugata
Burkholderia ambifaria Pseudomonas extremorientalis
Burkholderia anthina Pseudomonas fluorescens
Burkholderia cenocepacia Pseudomonas gessardii
Burkholderia cepacia Pseudomonas libanensis
Burkholderia diffusa Pseudomonas mandelii
Burkholderia dolosa Pseudomonas marginalis
Burkholderia lata Pseudomonas migulae
Burkholderia latens Pseudomonas mucidolens
Burkholderia metallica Pseudomonas orientalis
Burkholderia pyrrocinia Pseudomonas poae
Burkholderia seminalis Pseudomonas rhodesiae
Burkholderia stabilis Pseudomonas synxantha
Burkholderia vietnamiensis Pseudomonas tolaasii
Pseudomonas trivialis
Citrobacter amalonaticus complex Pseudomonas veronii
Citrobacter amalonaticus
Citrobacter farmeri Pseudomonas putida group
Pseudomonas fulva
Citrobacter freundii complex Pseudomonas monteilii
Citrobacter braakii Pseudomonas mosselii
Citrobacter freundii Pseudomonas plecoglossicida
Citrobacter gillenii Pseudomonas putida
Citrobacter murliniae
Citrobacter werkmanii Salmonella sp
Citrobacter youngae Salmonella enterica ssp arizonae
Citrobacter rodentium Salmonella enterica ssp bongori
Citrobacter sedlakii Salmonella enterica ssp diarizonae
Citrobacter koseri Salmonella enterica ssp enterica
Eikenella corrodens Salmonella enterica ssp houtenae
Enterobacter aerogenes Salmonella enterica ssp indica
Salmonella enterica ssp salamae
Enterobacter cloacae complex Serratia liquefaciens
Enterobacter asburiae Serratia marcescens
Enterobacter cancerogenus Stenotrophomonas maltophilia
Enterobacter cloacae Yersinia enterocolitica
Enterobacter hormaechei Yersinia pseudotuberculosis
Enterobacter kobei
Enterobacter ludwigii © BDAL 03-2014, 1825980, Revision A
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae

Bruker Daltonics Inc.

Billerica, MA · USA
Phone +1 (978) 663-3660
Fax +1 (978) 667-5993
[email protected]

www.bruker.com